FDA.reportPublic FDA data

Cook

Primary DI
00827002190276
Brand
Cook
Company
COOK INCORPORATED
Model
G19027
Catalog number
J-CVS-532400
Device description
Cook, Chorionic Villus Sampling Set
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLXCATHETER, SAMPLING, CHORIONIC VILLUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLXCatheter, Sampling, Chorionic VillusUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900007002
P900007004
P900007005
P900007006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900007002COOK CHORIONIC VILLUS SAMPLING SETCook Incorporated1994-09-30LLX
P900007004COOK CHORIONIC VILLUS SAMPLING SETCook Incorporated1994-09-30LLX
P900007005COOK CHORIONIC VILLUS SAMPLING SETCook Incorporated1994-09-30LLX
P900007006COOK CHORIONIC VILLUS SAMPLING SETCook Incorporated1994-09-30LLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002190276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002190276008270021902768270021902760827002190276

GMDN Terms#

Term, Definition table
TermDefinition
Chorionic villus sampling catheterA sterile flexible tube designed for transcervical chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorioinic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. The device usually includes a malleable, preshaped stylet, and is usually introduced under ultrasonographic guidance via the vagina/cervix. The suction for sampling is provided by an external syringe. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002169081CookCOOK INCORPORATEDLLX2014-09-24